Philadelphia Children's Hospital Bans Dietary Supplements

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The Children's Hospital of Philadelphia announced this week that
it has removed most dietary supplements from its list of approved
medications, and dissuading its patients' families from using
them.

The hospital, referred to as CHOP, is no stranger to experimental
treatments. Earlier this year, doctors there demonstrated how an
innovative new proton therapy precisely targets cancer growth in
children.

Yet the hospital is drawing a firm line when it comes to
unproven dietary supplements, those so-called natural
products hailed as cures for just about every ailment under the
sun.

The reason is that so many of these supplements — echinacea,
CoEnzyme Q10, and the like — are not regulated by any medical
authority, and are not proven to cure or treat any disease.
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"Because vitamins and dietary supplements are essentially
unregulated, there is no sound information about adverse side
effects, drug interactions, or even standard dosing for the vast
majority of them," said Sarah Erush, CHOP Pharmacy Clinical
Manager and a member of the hospital's Therapeutic Standards
Committee, which recommended the policy change that was rolled
out over the summer.

"Administering these medications — particularly to children with
serious health complications — is unethical when the risks are
unknown, and when there are alternative treatments that have been
proven in clinical trials to be safe and effective," Erush said.

The move makes CHOP the first hospital in the nation to place an
outright ban on most dietary supplements from its formulary, or
list of approved medications, although the hospital will still
administer a few essential vitamins, minerals and amino acids.

Although manufacturers are barred from making unproven health
claims on a product's label, any supplement's purpose — for
example, ginkgo for memory enhancement, or echinacea for colds —
is generally well-known by consumers through word of
mouth. Moreover, the Food and Drug Administration has had
difficulty ensuring the purity and the accuracy in labeling for
the thousands of dietary supplements sold in U.S. stores and over
the Internet.

Complicating issues further is that the Joint Commission, the
leading accrediting organization for hospital safety and quality,
expects hospitals to treat dietary supplements as drugs. The FDA,
on the other hand, regulates supplements more like a food.

"When the FDA doesn't regulate them, we get caught in the
middle," said Dr. Paul Offit, chief of the Division of Infectious
Diseases at CHOP and head of the Therapeutic Standards Committee.
Hundreds of patient families in just the past few months have
reported using supplements, said Offit, who has argued
against the use of unproven alternative medicine treatments
in the past.

Offit described his hospital's actions as a "clean sweep,"
removing the vast majority of dietary supplements from its
formulary. One supplement that the hospital will keep is
melatonin, because there is at least some data on its
effectiveness in treating sleep disorders.

As the use of dietary supplements has exploded in recent years,
doctors have faced an increasingly difficult task in knowing
exactly what their patients are taking.

Offit pointed to a recent case in which a previously healthy
child came to CHOP with severe pancreatitis (inflammation of the
pancreas). The child had been taking more than
90 different dietary supplements, he said.

One of the biggest concerns, Offit said, is the lack of good
manufacturing practices in the dietary supplement industry. Few
products — "0.001 percent," he estimated — are USP-verified,
meaning they meet standards set by the U.S. Pharmacopeial
Convention for ensuring the strength, quality and purity of a
product.

Offit said he is confident his hospital can obtain USP-verified
melatonin supplements, as well as the key vitamins, minerals and
amino acids and the few other supplements that remain on the
list.

A second concern is how the supplements interact with standard
medication. St. John's wort, an herb taken for depression, is
metabolized through the liver and can cause life-threatening side
effects when taken with certain medications. With most dietary
supplements, the risks are unclear, Offit said.

FDA-approved medication also certainly have side effects, Offit
said, but at least doctors understand what the dangers are
because they have been documented in studies. "Serious diseases
require serious medicine," Offit added.

Under the new policy, the parents and guardians of children
admitted to CHOP are asked to disclose any dietary supplement the
child is taking. Hospital staff then explain the issues with
these supplements and strongly recommend that the patient cease
taking them while under their care. If the patient's family
insists on continuing use of a supplement, then the guardians
must sign a waiver stating that they agree to be responsible for
providing the product.

CHOP might be leading the pack. A study published in 2008 in the
journal Pediatrics found that most children's hospitals are
deeply concerned about dietary supplements, citing conflict
between Joint Commission recommendations and FDA rules, and they
are crafting policy to deal with the issue. The Joint Commission
was unable to be reached for comment for this story.

Still, it might not be easy to wean patients off of dietary
supplements. There's a GNC store within a half mile of CHOP, and
more than dozen others in the area, where one could buy all of
the supplements the hospital now bans.

Christopher Wanjek is the author of a new novel, " Hey,
Einstein! ", a comical nature-versus-nurture tale about
raising clones of Albert Einstein in less-than-ideal settings.
His column, Bad Medicine,
appears regularly on LiveScience.